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The Use of Amber Glasses in Improving Sleep

Primary Purpose

Sleep Disturbance, Insomnia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Amber Glasses
Sponsored by
Surrey and Borders Partnership NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age over 18 years
  • Male or female gender
  • Presentation of mental illness (of psychotic nature, severe depression or anxiety)
  • Able to provide informed consent

Exclusion Criteria:

  • Patient does not consent
  • High risk assessment of self-harm or harm to others

Sites / Locations

  • Surrey and Borders NHS Foundation Trust

Outcomes

Primary Outcome Measures

The difference in the use of hypnotic medication as compared with existing data from a similar population.
Sleep quality will be assessed using the Pittsburgh Sleep Quality Assessment (PSQI) tool at baseline and at the 2 and 4 weeks. At the end of the study period, percentage use of amber glasses and zopiclone will be used to compare against a historical average of hypnotic use for the most recent 15 admissions over a similar 4 week period. These historic admissions will be matched for diagnosis.

Secondary Outcome Measures

Change in sleep quality as measured by a point score change in the PSQI.

Full Information

First Posted
February 5, 2021
Last Updated
February 10, 2021
Sponsor
Surrey and Borders Partnership NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04751019
Brief Title
The Use of Amber Glasses in Improving Sleep
Official Title
The Use of Amber Glasses in Improving Sleep and Reducing the Use of Hypnotic Medication in an Inpatient Mental Health Setting: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Surrey and Borders Partnership NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The use of amber glasses will aid the patient to fall asleep without the need for the use of hypnotic medication.
Detailed Description
Sleep disturbance and insomnia is extremely common and affects up to 30% of adults at any given time. Moreover, sleep disturbance is known to be particularly prevalent in patients suffering from mental illness including affective disorders, schizophrenia, anxiety (Baglioni, 2016). We hypothesise that the use of amber glasses will aid the time taken to fall asleep without the need for the use of hypnotic medication.A prospective study looking at 15 new patients admitted to one mental health ward will be undertaken. Data will be collected on twice weekly basis on the patient's use of: amber glasses alone, hypnotic medication alone or both. Hypnotic medication will include sedating antihistamines, benzodiazepines and non-benzodiazepine hypnotics such as zopiclone. Medication prescribed for dual purpose will be assumed to be used for the treatment of insomnia if given after 2300 hours. Each patient will be enrolled for a period of 4 weeks and the review of use and suitability will take place in ward review meetings. Sleep quality will be assessed using the Pittsburgh Sleep Quality Assessment tool at baseline and at the 2 and 4 weeks. At the end of the study period, percentage use of amber glasses and zopiclone will be used to compare against a historical average of hypnotic use for the most recent 15 admissions over a similar 4 week period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Amber Glasses
Intervention Description
It is hoped that the use of amber glasses to complement the natural sleep-wake by inducing a perceived 'physiological darkness' to aid the secretion of melatonin should help sleep and reduce the use of hypnotic medication
Primary Outcome Measure Information:
Title
The difference in the use of hypnotic medication as compared with existing data from a similar population.
Description
Sleep quality will be assessed using the Pittsburgh Sleep Quality Assessment (PSQI) tool at baseline and at the 2 and 4 weeks. At the end of the study period, percentage use of amber glasses and zopiclone will be used to compare against a historical average of hypnotic use for the most recent 15 admissions over a similar 4 week period. These historic admissions will be matched for diagnosis.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in sleep quality as measured by a point score change in the PSQI.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age over 18 years Male or female gender Presentation of mental illness (of psychotic nature, severe depression or anxiety) Able to provide informed consent Exclusion Criteria: Patient does not consent High risk assessment of self-harm or harm to others
Facility Information:
Facility Name
Surrey and Borders NHS Foundation Trust
City
Leatherhead
State/Province
Surrey
ZIP/Postal Code
KT22 7AD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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The Use of Amber Glasses in Improving Sleep

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